Effectiveness of bracing patients with adolescent idiopathic scoliosis
| ISRCTN | ISRCTN36964733 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN36964733 |
| Protocol serial number | NTR563; ZonMw no. 945-06-354 |
| Sponsor | Erasmus Medical Centre (Netherlands) |
| Funders | Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands), Erasmus University Rotterdam (Association trust fund [Vereniging Trustfonds]) (Netherlands), The Nuts Ohra Foundation (Stichting Nuts Ohra) (Netherlands) |
- Submission date
- 14/02/2006
- Registration date
- 14/02/2006
- Last edited
- 18/08/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Ms E.M. Bunge
Scientific
Scientific
Erasmus Medical Centre
Department of Public Health
P.O. Box 1738
Rotterdam
3000 DR
Netherlands
| Phone | +31 (0)10 4087498 |
|---|---|
| e.bunge@erasmusmc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre randomised open label active controlled parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Bracing patients with adolescent idiopathic scoliosis in an early stage results in at least 5 degrees less mean progression of the curvature compared to the control group after two years of follow up. |
| Ethics approval(s) | Received from local medical ethics committee |
| Health condition(s) or problem(s) studied | Adolescent Idiopathic Scoliosis (AIS) |
| Intervention | Patients in the intervention group will be treated with a brace. The brace is a device that fits closely around the body to exert pressure to the trunk in order to push the spine into a straighter position. The patients will be advised to wear the brace every day for 18-23 hours. Patients are allowed to go to physiotherapy if they want to, but this is not obligatory. Patients of the control group will initially not be braced during the two study years, unless their curvature shows more than 10 degrees progression compared to the Cobb angle at inclusion. The patients of the control group are allowed to go to physical therapy, because physical therapy alone will not prevent further progression of the curvature. The orthopaedic surgeons will examine all patients every four months, amongst other things by X-ray. |
| Intervention type | Other |
| Primary outcome measure(s) |
Cobb angle, two years after inclusion. |
| Key secondary outcome measure(s) |
1. Quality of life |
| Completion date | 31/03/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 8 Years |
| Upper age limit | 15 Years |
| Sex | All |
| Target sample size at registration | 100 |
| Key inclusion criteria | 1. Firls and boys in the age group 8-15 years 2. Diagnosis of AIS has been established by an orthopaedic surgeon 3. not yet been treated by bracing or surgery 4. Further growth of physical height is still expected based on medical examination and maturation characteristics (Risser sign) established by X-ray. To expect further growth of physical height, patients only with Risser sign <3 will be included. 5. As agreed in the consensus by the different health professionals in the orthopaedic field, the Cobb angle should either be minimally 22 and maximally 29 degrees with established progression of more than 5 degrees or should be minimally 30 and maximally 35 degrees; progression for the latter is not necessarily established. |
| Key exclusion criteria | Patients with other forms of scoliosis (e.g. as a result of neuromuscular diseases) |
| Date of first enrolment | 19/01/2006 |
| Date of final enrolment | 31/03/2009 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Erasmus Medical Centre
Rotterdam
3000 DR
Netherlands
3000 DR
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | Protocol | 22/04/2008 | Yes | No |
